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Completed

NCT Number: NCT01599104

Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Japanese Patients With Essential Hypertension

This study assessed the efficacy of LCZ696 in Japanese patients with essential hypertension

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Kamogawa, Chiba, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with mild-to-moderate hypertension, untreated or currently taking antihypertensive therapy.
  • Treated patients (using antihypertensive treatments within 4 weeks prior to Visit 1) must have an msSBP ≥ 150 mmHg and < 180 mmHg at the randomization visit (Visit 201) and msSBP ≥140 mmHg < 180 mmHg at the visit immediately proceeding Visit 201 (Visit 102 or 103).
  • Untreated patients (newly diagnosed with essential hypertension or having a history of hypertension but have not been taking any antihypertensive drugs for at least 4 weeks prior to Visit 1) must have an msSBP ≥ 150 mmHg and < 180 mmHg at both Visit 1 and Visit 201.
  • Patients must have an absolute difference of ≤15 mmHg in msSBP between Visit 201 and the immediately preceding visit;

Exclusion criteria

  • Severe hypertension (msDBP ≥110 mmHg and/or msSBP ≥ 180 mmHg).
  • History of angioedema, drug-related or otherwise, as reported by the patient.
  • History or evidence of a secondary form of hypertension, including but not limited to any of the following: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension.
  • Patients who previously entered a LCZ696 study and had been randomized or enrolled into the active drug treatment epoch.

Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

LCZ696

Drug

200 mg (one tablet) or 400 mg (2 tablets of 200mg) once daily

Olmesartan

Drug

Olmesartan 20 mg capsule one daily

Placebo

Drug

Placebo to LCZ696 or Olmesartan

Primary outcomes

  1. Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)

    Time frame: Baseline, 8 weeks

    Sitting BP measurements were performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurements. The 4 measurements were summed and averaged, and then the baseline BP value was subtracted from the average value to get the change from baseline.

Secondary outcomes

  1. Change From Baseline in Mean 24-hour Ambulatory SBP (maSBP) at Week 8

    Time frame: Baseline, 8 weeks

    Ambulatory blood pressure monitoring (ABPM) over a 24-hour period was conducted at two time-points during the study in a subset of participants.

  2. Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)

    Time frame: Baseline, 8 weeks

    Sitting BP measurement was performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurement. The 4 measurements were summed and averaged, and then the baseline BP value was subtracted from the average value to get the change from baseline.

  3. Percentage of Participants Achieving a Successful Response in Overall Blood Pressure Control at Week 8

    Time frame: 8 weeks

    A successful response in overall BP control rate was defined as msSBP < 140 mmHg and msDBP <90 mmHg.

  4. Percentage of Participants Achieving a Successful msSBP Response

    Time frame: 8 weeks

    Successful msSBP response was defined as < 140 mmHg or ≥ 20 mmHg reduction from baseline.

  5. Percentage of Participants Achieving a Successful msDBP Response

    Time frame: 8 weeks

    Successfull msDBP response was defined as <90 mmHg or ≥10 mmHg reduction from baseline.

  6. Change From Baseline in Mean 24-hour Ambulatory DBP (maDBP) at Week 8

    Time frame: Baseline, 8 weeks

    ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants.

  7. Change From Baseline in maSBP and maDBP for Daytime/Nighttime

    Time frame: Baseline, 8 weeks

    ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants.

  8. Change From Baseline in Office Pulse Pressure

    Time frame: Baseline, 8 weeks

    Office pulse pressure was calculated as msSBP minus msDBP. Sitting blood pressure (BP) measurement was performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurement. The 4 measurements were summed and then averaged to calculate the mean BP value. The baseline PP value was subtracted from the week 8 PP value to determine the change from baseline in PP.

  9. Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure

    Time frame: Baseline, 8 weeks

    Ambulatory pulse pressure was calculated as hourly ambulatory SBP minus hourly ambulatory DBP in a subset of participants.

  10. Number of Patients With Adverse Events, Serious Adverse Events and Death

    Time frame: 8 weeks

    Participants were monitored for adverse events, serious adverse events and deaths throughout the study.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Multi-center, Randomized, Double-blind, Active-controlled, 8-week Study to Evaluate the Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Japanese Patients With Essential Hypertension

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 15, 2012
Registry last updated
Oct 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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